BEUDAMED
    FDA Enforcement Class II Terminated

    Medtronic O-arm Imaging System Product Usage: image-intensified fluoroscopic x-ray system, mobile

    Recall: Z-0926-2013 · Reported March 20, 2013

    Enforcement

    Recall Number
    Z-0926-2013
    Event ID
    64256
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medtronic Navigation, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 20, 2013
    Initiation Date
    January 31, 2013
    Classification Date
    March 8, 2013
    Termination Date
    July 6, 2016
    Address
    300 Foster St, N/A, Littleton, MA, 01460-2017, United States

    Description

    Medtronic O-arm Imaging System Product Usage: image-intensified fluoroscopic x-ray system, mobile

    Reason

    Potential failure of the braking system that controls the O-arm Imaging System gantry movement in the vertical direction

    Code Info

    Product Catalog Numbers: 9732719, 9732719R, 9733346, 9733346R, BI-700-00027, BI-700-00027R, BI-700-00027-GER, BI-700-00027-GERR, BI-700-00027-100, BI-700-00027-100R, BI-700-00027-120, BI-700-00027-120R, BI-700-00027-230, BI-700-00027-230R Units with serial numbers 101 through 564 and unit 580 are affected. Serial numbers 565 and higher are not affected .

    Distribution

    Worldwide Distribution - USA Nationwide and the countries of: Canada, AUSTRIA, BELGIUM, BRAZIL, BULGARIA, CHILE, CHINA, CROATIA, CZECH REPUBLIC, DENMARK,FINLAND, FRANCE, GERMANY, GREECE, INDIA, IRELAND, ISRAEL, ITALY, JAPAN ,KOREA, REPUBLIC OF KUWAIT, LEBANON, LIBYAN ARAB JAMAHIRIYA, MEXICO, NETHERLANDS, New Zealand, POLAND, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, Taiwan(R.O.C.) , THAILAND, TURKEY, UNITED ARAB EMIRATES. and UNITED KINGDOM.

    Quantity

    463 units